Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist S… (NCT01187368) | Clinical Trial Compass
SuspendedNot Applicable
Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System
Stopped: Subject recruitment is temporarily on hold due to ongoing device modification.
United States399 participantsStarted 2020-03-31
Plain-language summary
This is a prospective, multi-center, unblinded, randomized, controlled, and non-inferiority study comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3 LVAS).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy
. Technical obstacles which pose an inordinately high surgical risk
. Existence of ongoing mechanical circulatory support (MCS) other than IABP and Impella 5.0 or 5.5
. Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) and elevated LDH equal or greater than 600 IU/L.
. Positive pregnancy test if of childbearing potential
. Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis
. History of any organ transplant
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.